Skip to content
type1.science
Phase 2RecruitingNCT06964087

OPT101 Phase 2 subcutaneous PK and pilot efficacy in T1D

What this study tests

Recruiting US Phase 2 of subcutaneous OPT101 per the registry. Part A is open-label dose-finding (three times weekly for two weeks); Parts B and C are 48-week placebo-controlled C-peptide cohorts. This is the sponsor's follow-on after the completed Phase 1b (NCT05428943). No efficacy results.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-04-06.

Most recent recorded citation date: 2026-04-06. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Adults 18–50 with T1D per the registry. Part A: diagnosed within 20 years. Part B: 1–10 years and mixed-meal C-peptide 0.2 ng/mL (about 0.07 nmol/L). Parts B and C per the registry require Th40 at least 35% of CD3+ cells. Part C: diagnosed within one year and mixed-meal C-peptide 0.2 ng/mL. Participants wear a CGM (registry example FreeStyle Libre 3). Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
No results. Recruiting; estimated n=72; start 10 April 2026 (registry-estimated); estimated primary completion 31 May 2026 (that date has passed; the registry is still recruiting and has not posted results) and estimated study completion 19 August 2028. Last registry update 6 April 2026. A passed estimated primary-completion date is not a result.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Change from baseline to week 48 in mixed-meal stimulated C-peptide

The full picture

Phase 1b (NCT05428943) gave OPT101 by infusion (eight 30-minute infusions over 42 days in the posted registry results) and posted small safety tables with no C-peptide advantage over placebo. This Phase 2 uses a subcutaneous formulation, three times weekly per the registry, and asks whether a year of the highest tolerated dose changes mixed-meal C-peptide.

Per the registry, Part A is 18 people, open-label, two weeks (three times weekly). Parts B and C are randomised 2:1 drug versus dextrose-matched placebo for 48 weeks (27 people each as designed). The protocol uses mixed-meal C-peptide in ng/mL; 0.2 ng/mL is about 0.07 nmol/L. A registered, recruiting protocol is not an efficacy result.

Sources

  1. [1]